ROCKVILLE, Md. - The Food and Drug Administration (FDA) recently proposed two regulations designed to improve the safety of fresh and processed fruit and vegetable juices. FDA officials anticipate that the labeling provisions will be finalized by this fall's apple harvest.
The proposed manufacturing changes defined by the regulations would in crease protection against harmful microbes and other contaminants in juices.
This plan comes after several outbreaks of foodborne illness in recent years. The FDA estimates between 16,000 and 48,000 cases of juice-related illnesses occur each year.
The first proposed regulation would require domestic and foreign processors of packaged fruit and vegetable juices to implement hazard control programs at their plants to prevent microbiological, chemical and physical contamination of all products sold in the United States. Manufacturers of unpasteurized juices would also be required to adjust their processes to achieve a 100,000-fold reduction in the number of harmful microbes in their finished products, as compared with levels that may be present in untreated juice, according to a statement from the FDA.
The second regulation would require warning labels on all packaged juice products that have not been pasteurized or otherwise treated to eliminate harmful microbes.
The required changes in the production process would use the Hazard Analysis and Critical Control Point system (HACCP), a scientifically designed program that identifies the steps in food production where contamination most likely occurs and then puts preventive controls in place.
HACCP programs are already federally required at seafood, meat and poultry processing plants.
The HACCP regulation would apply to all domestic and foreign juice manufacturers that sell products in the United States and is aimed at juice manufacturers who distribute packaged products to consumers. Locations where juice is made and consumed on the premises (a child's lemonade stand, juice bar, or restaurant) would not be affected.
Fresh juice processors would be required to use processes that reduce the number of harmful microbes to the same level achievable by pasteurization, but would be free to employ microbial reduction methods other than pasteurization, including washing, scrubbing, anti-microbial solutions, alternative technologies or a combination of techniques.
Once the HACCP regulation is finalized, implementation would allow a year for large manufacturers, two years for small businesses, and three years for very small businesses.
Given the phase-in periods required to implement the HACCP regulation, a labeling rule has also been proposed. This rule would require manufacturers of juices that are not pasteurized or otherwise treated to kill microbes to put a warning label on containers, advising consumers of the potential risk of consuming untreated products.
The label would state: "WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria which can cause serious illness in children, the elderly and persons with weakened immune systems."
Warning labels would not be required on juice products that are processed under HACCP programs or that are treated to reduce harmful microbes.
Outbreaks from cider and juice have been recognized for decades. Sporadic cases are probably common but unrecognized. Unpasteurized cider and juice can transmit pathogens. Current production practices do not guarantee the safety of apple juice, apple cider and orange juice, according to Michael Friedman, MD, deputy commissioner for operations with the FDA.
Following two outbreaks of Escherichia coli O157:H7 traced to apples in 1996, the FDA called on experts in the medical field, juice manufacturers and fruit growers to evaluate and review the technologic and safety factors associated with fresh juices.
The first outbreak in 1996 occurred in Connecticut where 10 cases of E. coli 157:H7 were reported, three of which involved children. The cases were linked to drinking fresh apple cider. Although there were no deaths, three cases of hemolytic uremic syndrome (HUS) were discovered, a high percentage considering previous studies showed only 5% of cases go on to develop HUS.
Another 1996 outbreak of E. coli 157:H7 struck 66 people in three western states and British Columbia. Ten children developed HUS and one child died. All cases were linked to juice manufactured by Odwalla Inc.
Until the FDA-proposed ruling be comes effective, the Centers for Disease Control and Prevention said consumers can reduce their risk for enteric infections by only drinking pasteurized or boiled apple cider and juice.
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